MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Tachycardia (2095); Tingling (2171); Loss of consciousness (2418)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with a trial external neurostimulator (ens) for urgency frequency.Patient stated that on the left side the heart began to beat very fast.Patient then changed to the right side and the issue was resolved.Patient reported again on (b)(6) 2018 that the therapy was off due to a tingling sensation all over their body.They further reported that they believed that they had a blacked out seizure and "has" had 4 since the evaluation started, whereas before they would only have about one per month.Patient would "be" follow up with their health care professional to get their be lead removed.No further complications were noted or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with a trial external neurostimulator (ens) for urgency frequency patient stated that on the left side the heart began to beat very fast.Patient then changed to the right side and the issue was resolved.Patient reported again on (b)(4) 2018 that the therapy was off due to a tingling sensation all over their body.They further reported that they believed that they had a blacked out seizure and has had 4 since the evaluation started, whereas before they would only have about one per month.Patient would be follow up with their health care professional to get their be lead removed.No further complications were noted or anticipated.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8000479
• MDR Text Key: 124976689
• Report Number: 3007566237-2018-03128
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 10/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR